A Major Medical Devices Company in Galway, Ireland wish to recruit a suitably qualified person for the following post:
SENIOR DESIGN QUALITY ENGINEER
At our Design Quality department, we focus on providing Engineering support for Quality Compliance and Risk Management activities, across the Ventilation portfolio. As a Senior Design Quality Engineer, you will support the application of Design Controls in Product Development and Sustaining Changes, through analyzing customer complaints, conducting risk management reviews and ensuring that all design changes are compliant to associated Regulations and Methods.
A DAY IN THE LIFE OF:
* Responsible for ensuring that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations and EU MDD / MDR requirements.
* Responsible for reviewing new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.
* Participate on cross-functional teams to develop and maintain Product Risk Management Files (Risk Management Plan, Risk Assessments, DFMEA and Risk Management Report) and facilitate Post Launch Risk Management Reviews.
* Participate in the development of Design Verification and Validation test plans / protocols and provide guidance on Product Requirements compliance. Participate in engineering Design Reviews.
* Provide guidance and direction for sample size and statistical analysis of Verification and Validation testing.
* Provide training to project teams on all Quality Policies / Procedures (including verification, validation, statistical methods and design controls), when necessary.
* Provide Quality support to facilitate the rapid resolution of Product Complaints and/or Patient Safety issues.
* Review Design History Files and Technical Files for conformance to applicable requirements and support the Regulatory Department in reviewing technical submissions.
KEY SKILLS & EXPERIENCE
* Bachelor's Degree level 8 (No equivalencies)
* 5+ years industry experience Quality Assurance or Regulatory Affairs for a Medical Device or Pharmaceutical Industry.
* Knowledge of Medical Device Quality Systems (21 CFR 820, ISO13485, MDD and MDR) and/or Pharmaceutical GMP (21 CFR 210/211).
* Experience with FDA and International Regulatory agency requirements, CE marking (MDD / MDR).
* Knowledge and Experience in developing and manufacturing medical devices in conformance with Quality System Regulation, ISO13485 and ISO 14971 requirements.
* Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills and interpersonal skills.
* Ability to effectively manage multiple projects and priorities. Experience working with cross-functional teams.
* Proficient skills with MS Word, MS Outlook, MS Excel.
REMUNERATION: An excellent Salary/Benefits Package is on offer and negotiable
Please forward your CV in WORD FORMAT to:
Informal enquiries to Christy O'Hara on 087-9473404 or 00353 879473404 (if outside Ireland)